Prescription drug · NDA
Ertaczo (Sertaconazole nitrate) NDC 85437-004
Sertaconazole nitrate 20 mg/g · Cream · Topical · Coral Way Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85437-004-60 | 85437000460 | 1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBEMarketed from Nov 7, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ertaczo
- Generic name (nonproprietary)
- sertaconazole nitrate
- Active ingredients
- Sertaconazole nitrate — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Coral Way Pharma, LLCNDC labeler code 85437
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021385
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 85437-004_4ee1de22-cab4-606f-e063-6394a90afd63SPL ID 4ee1de22-cab4-606f-e063-6394a90afd63SPL set ID c6fa8dc4-2620-474e-a9b4-6657d9cbfa96RxCUI 250511, 580294UNII 1DV05410M5UPC 0385437004600
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485437000460followed by a unit qualifier and the quantityPackage 85437-0004-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum , Trichophyton mentagrophytes, and Epidermophyton floccosum . ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum . ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 85437-004
- What is NDC 85437-004?
- 85437-004 is the product NDC for Ertaczo (sertaconazole nitrate), Sertaconazole nitrate 20 mg/g cream, listed with the FDA by Coral Way Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ertaczo (Sertaconazole Nitrate).
- What is the active ingredient?
- Sertaconazole nitrate.
- Who is the labeler?
- Coral Way Pharma, LLC, NDC labeler code 85437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ertaczo?
- 1 other product NDC are listed under this name. See all Ertaczo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ertaczo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ertaczosertaconazole nitrate | Sertaconazole nitrate 20 mg/g | CreamTopical | Lacer Pharma, LLC | 73159-004 | 73159-0004-60 |
Other NDCs under NDA 021385
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ertaczosertaconazole nitrate | Sertaconazole nitrate 20 mg/g | CreamTopical | Lacer Pharma, LLC | 73159-004 |